Validation Associate Engineer
Bristol Myers Squibb
July 02, 2026
On-site
Bothell, WA
Operations
The Validation Associate Engineer ensures compliance with GMP asset management and validation requirements in a regulated GMP manufacturing facility.
Key Responsibilities:
- Support Periodic Review and Periodic Requalification programs at BMS sites in Bothell, WA and Seattle, WA, including temperature mapping studies and development of Periodic Reviews.
- With oversight, generate validation protocols, specifications, reports, and qualification plans for GMP operations.
- Perform Validation Impact Assessments for on-demand work orders of qualified equipment, utilities, and facilities.
- Support qualification work arising from change controls, capital projects, and supplemental validation deliverables under approved validation plans.
- Collaborate with cross-functional teams (Facilities & Engineering, IT, Manufacturing, QC, Supply Chain, QA, Quality Engineering Validation).
Qualifications & Experience (Required/Recommended):
- Bachelor’s degree in life sciences/engineering/STEM or equivalent.
- 2 years’ GMP experience (preferably pharmaceutical manufacturing operations or support).
- Recommended: commissioning, qualification, and validation (CQV) in regulated industries.
- Awareness of cGMP/GDP/GXP/GAMP5, including 21 CFR Part 11, computer systems validation, EU GMP Annex 15, and data integrity.
- Beneficial: equipment/utility/facility qualifications and CQV practices; investigations/deviations/CAPA.
- Beneficial: validation lifecycle deliverables (URS through IQ/OQ/PQ and SR) and computer system validation (CSV) through retirement.
- Required: strong project/program management, communication, and technical writing skills.
- Desired: electronic document management systems for quality/validation documents.
Compensation/Benefits (explicitly stated):
- Bothell, WA: US $83,220–$100,847.
- Health coverage; wellbeing programs; 401(k), disability and insurance.
- Paid Time Off includes flexible time off and national holidays (details vary by location/role).
Application Instructions:
- Apply even if the role doesn’t perfectly match your resume.
Key Responsibilities:
- Support Periodic Review and Periodic Requalification programs at BMS sites in Bothell, WA and Seattle, WA, including temperature mapping studies and development of Periodic Reviews.
- With oversight, generate validation protocols, specifications, reports, and qualification plans for GMP operations.
- Perform Validation Impact Assessments for on-demand work orders of qualified equipment, utilities, and facilities.
- Support qualification work arising from change controls, capital projects, and supplemental validation deliverables under approved validation plans.
- Collaborate with cross-functional teams (Facilities & Engineering, IT, Manufacturing, QC, Supply Chain, QA, Quality Engineering Validation).
Qualifications & Experience (Required/Recommended):
- Bachelor’s degree in life sciences/engineering/STEM or equivalent.
- 2 years’ GMP experience (preferably pharmaceutical manufacturing operations or support).
- Recommended: commissioning, qualification, and validation (CQV) in regulated industries.
- Awareness of cGMP/GDP/GXP/GAMP5, including 21 CFR Part 11, computer systems validation, EU GMP Annex 15, and data integrity.
- Beneficial: equipment/utility/facility qualifications and CQV practices; investigations/deviations/CAPA.
- Beneficial: validation lifecycle deliverables (URS through IQ/OQ/PQ and SR) and computer system validation (CSV) through retirement.
- Required: strong project/program management, communication, and technical writing skills.
- Desired: electronic document management systems for quality/validation documents.
Compensation/Benefits (explicitly stated):
- Bothell, WA: US $83,220–$100,847.
- Health coverage; wellbeing programs; 401(k), disability and insurance.
- Paid Time Off includes flexible time off and national holidays (details vary by location/role).
Application Instructions:
- Apply even if the role doesn’t perfectly match your resume.